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Analysis of the effects of adding Pregabalin to the treatment of postoperative pain control in Hemorrhoid Surgery

Efficacy of Pregabalin as an adjuvant in multimodal pain control after Hemorrhoidectomy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-7d4ff6q
Enrollment
Unknown
Registered
2025-12-19
Start date
2025-12-08
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Interventions

This is a randomized, double-blind, two-arm clinical trial. A total of 72 patients will be recruited, with 36 patients in each arm. Patients will be randomized and allocated into two groups: Pregabali
s dosage, which consists of a loading dose administered two hours before surgery and maintained every 12 hours until the seventh postoperative day
The preemptive loading dose will be 150 mg, which, according to a study by Asgari (2017) comparing the effect of administering different doses of pregabalin 2 hours before laparoscopic hysterectomy, w

Sponsors

Escola Paulista de Medicina da Universidade Federal de São Paulo
Lead Sponsor
Hospital Estadual de Diadema
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ASA 1 to 3 by the American Society of Anesthesiology; ages between 18 and 65 years; of both sexes; with grade III or IV hemorrhoidal disease indicated for Milligam-Morgan hemorrhoidectomy

Exclusion criteria

Exclusion criteria: Patients with cardiac arrhythmias; cardiomyopathy and/or cardiac conduction disorders; psychiatric, liver, respiratory, or oncological diseases; cognitive impairments that prevent proper completion of the forms; using analgesics in the week prior to surgery; associated surgeries; hypersensitivity to medications; active user of psychoactive drugs; consent forms signed incorrectly or without signature

Design outcomes

Primary

MeasureTime frame
It is expected that higher pain reduction scores will be found in the group that used pregabalin in combination with other medications, based on the assumption that the postoperative visual analog scale pain score in the pregabalin group would be 35 mm, compared to 50 mm in the placebo group, with a standard deviation of 20 mm.

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactRicardo Akiba

Escola Paulista de Medicina da Universidade Federal de São Paulo

ricardo.akiba@gmail.com+55 (11) 3385-4343

Outcome results

None listed

Source: REBEC (via WHO ICTRP)